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OMNI DENT Omnisuc Cleaner
EUDAMEDClass I (EU MDR)
Ref 55153Model 114
by PRISMAN GmbH
Identity
- Trade Name
- OMNI DENT Omnisuc Cleaner EUDAMED
- Device Name
- Absauganlagenreiniger D ZYME Konz., SSC 200 conc. EUDAMED
- Model / Reference
- 114 EUDAMED55153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797027264 EUDAMED
- Basic UDI-DI
- ++EPRM114DG EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Medical device disinfection agent
OMNI DENT Omnisuc Cleaner by PRISMAN GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EPRM114DG | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED fa1db925-ff5e-4ec3-bd9e-b3c77b709c05 61 fields · synced Jul 18, 2026